HB05P on Muscle Health

Pusan National University Yangsan Hospital80 enrolled

Overview

The purpose of this pilot study is to evaluate whether HB05P, a health functional food ingredient containing pasteurized Akkermansia muciniphila HB05, improves muscle strength, and to evaluate its safety. This is a randomized, double-blind, placebo-controlled, parallel-group, single-center study. A total of 80 adults aged 50 to under 80 years who meet the 2025 Asian Working Group for Sarcopenia (AWGS) criteria for sarcopenia or possible sarcopenia will be randomly assigned in a 1:1 ratio to the test group or the control group. Participants will take one 430 mg hard capsule once daily with water after breakfast for 168 days (24 weeks). The test capsule contains 150 mg of HB05P (3 x 10\^10 cells per day); the control capsule contains microcrystalline cellulose and is identical in appearance and packaging. All participants are asked to perform 30 to 60 minutes of walking and resistance exercise at least 3 times per week throughout the study and to keep an exercise diary and an intake diary. The primary outcome is the change from baseline in peak torque per body weight (Nm/kg) of the quadriceps and hamstrings, measured with an isokinetic dynamometer at an angular velocity of 60 degrees per second and averaged across the left and right sides. Secondary outcomes include average power, muscle strength, muscle mass measured by dual-energy X-ray absorptiometry, handgrip strength, Short Physical Performance Battery scores, muscle-related blood markers, and quality of life. Efficacy and safety are assessed at baseline (Day 0), Week 12 (Day 84), and Week 24 (Day 168).

Study design This is a randomized, double-blind, placebo (comparator food)-controlled, parallel-group, single-center exploratory (pilot) clinical trial of a health functional food ingredient. Eligible participants who provide written informed consent are randomly assigned 1:1 to the test group or the control group. Sample size 64 participants (32 per group) are required for efficacy evaluation. Allowing for a 20 percent dropout rate, 80 participants (40 per group) will be enrolled. Study population Adults aged 50 to under 80 years who meet the 2025 AWGS criteria for sarcopenia or possible sarcopenia. Muscle mass is assessed as ASM/height\^2 by bioelectrical impedance analysis, handgrip strength as the maximum value of the dominant hand, and physical performance by the 5-time chair stand test of the Short Physical Performance Battery. Investigational products Test food: one hard capsule of 430 mg containing 150 mg HB05P (pasteurized Akkermansia muciniphila HB05), microcrystalline cellulose, silicon dioxide, and magnesium stearate. Control food: one hard capsule of 430 mg containing microcrystalline cellulose, silicon dioxide, and magnesium stearate, without HB05P. Both capsules are manufactured to be indistinguishable in internal and external appearance and are supplied in identical packaging. Dosing One capsule once daily with water after breakfast for 168 days (24 weeks). Study food is dispensed at Visit 2 and Visit 3, 92 capsules at each visit. Intake is recorded by the participant in an intake diary, and compliance is checked at Visit 3 and Visit 4. Blinding Randomization code assignment is kept sealed by the principal investigator and is not disclosed until the end of the study. If emergency unblinding is required for a serious adverse reaction, only the assignment of the individual participant can be opened, using participant-specific sealed envelopes. The randomization code is opened for efficacy analysis after study completion. Visit schedule Visit 1, screening, Day -14 to Day -1: informed consent, eligibility assessment, demographics, medical and medication history, physical examination, eligibility tests, vital signs, clinical laboratory tests. Visit 2, baseline, Day 0: eligibility assessment, physical examination, clinical laboratory tests, efficacy assessments, questionnaires, concomitant medication check, dispensing of study food. Visit 3, Day 84 plus or minus 8 days: physical examination, vital signs, clinical laboratory tests, efficacy assessments, questionnaires, adverse event check, concomitant medication check, compliance check, dispensing of study food. Visit 4, Day 168 plus or minus 8 days: physical examination, vital signs, clinical laboratory tests, efficacy assessments, questionnaires, adverse event check, concomitant medication check, compliance check. Efficacy assessments (Visit 2, Visit 3, Visit 4) Isokinetic dynamometry at 60 degrees per second: peak torque per body weight of the quadriceps and hamstrings (right, left, dominant, non-dominant, and the average of left and right), average power (right, left, dominant, non-dominant, and the average of left and right), and muscle strength (right, left, dominant, non-dominant, and the average of left and right). Dual-energy X-ray absorptiometry: absolute skeletal muscle mass, ASM/height\^2, ASM/weight x 100, skeletal muscle mass/height\^2, lower-limb muscle mass, and body fat percentage (total, trunk). Handgrip strength (right, left, dominant, non-dominant, and the average of left and right). Short Physical Performance Battery total score and subscores. Blood markers: creatinine, total protein, albumin, prealbumin, C-reactive protein, creatine kinase, insulin-like growth factor 1, follistatin, and myostatin. Quality of life by EQ-5D-5L, a 24-hour dietary recall, and an exercise diary. Safety assessments Adverse events, vital signs, physical examination, and clinical laboratory tests are collected at the scheduled visits and evaluated for severity and causal relationship to the study food. Concomitant exercise All participants perform walking and resistance exercise for 30 to 60 minutes at least 3 times per week until the end of the study and record it in an exercise diary.

Eligibility

Sex: ALLMin age: 50 YearsMax age: 79 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Men or women aged 50 to under 80 years * Meeting the 2025 Asian Working Group for Sarcopenia (AWGS) criteria for sarcopenia (low muscle mass and low handgrip strength) or possible sarcopenia (low muscle mass with either low handgrip strength or low physical performance). Low muscle mass is defined as ASM/height\^2 measured by bioelectrical impedance analysis below 7.6 kg/m\^2 for men and below 5.7 kg/m\^2 for women aged 50 to 64 years, and below 7.0 kg/m\^2 for men and below 5.7 kg/m\^2 for women aged 65 years or older. Low handgrip strength is defined as the maximum value of the dominant hand at or below the following thresholds: 34.5 kg for men and 22.0 kg for women aged 50 to 54 years; 33.5 kg for men and 21.5 kg for women aged 55 to 59 years; 31.0 kg for men and 20.0 kg for women aged 60 to 64 years; 29.0 kg for men and 19.0 kg for women aged 65 to 69 years; 27.5 kg for men and 18.0 kg for women aged 70 to 74 years; 26.0 kg for men and 16.8 kg for women aged 75 to 79 years. Low physical performance is defined as more than 10 seconds on the 5-time chair stand test of the Short Physical Performance Battery for participants aged 50 to 64 years, and more than 12 seconds for those aged 65 years or older. * Not having participated in a commercial exercise program or performed regular resistance exercise 2 or more times per week within the 3 months before study participation * Physically able to participate in the standardized resistance exercise program provided from the start of the study at least 3 times per week, and willing to comply with it * Having received a full explanation of the purpose and procedures of the study and having voluntarily provided written informed consent Exclusion Criteria: * Short Physical Performance Battery total score of 3 or less * Cachexia or unintentional weight loss of 5 percent or more within the past 3 months * History of fracture or musculoskeletal surgery within the past 6 months * Musculoskeletal or functional limitation that precludes isokinetic strength testing or performance of the standardized exercise program (for example, severe osteoarthritis or rheumatoid arthritis) * Uncontrolled or clinically unstable endocrine disease (for example, Cushing syndrome or adrenal insufficiency) * Severe respiratory disease (COPD GOLD stage III to IV or long-term oxygen therapy) * Uncontrolled hypertension (systolic blood pressure 160 mmHg or higher, or diastolic blood pressure 100 mmHg or higher), uncontrolled diabetes mellitus (fasting glucose 160 mg/dL or higher), or uncontrolled thyroid disease * Major cardiovascular or cerebrovascular event within the past 6 months (acute myocardial infarction, stroke, unstable angina, percutaneous coronary intervention, or coronary artery bypass grafting) * History of malignancy within 3 years before screening or currently receiving anticancer treatment, except malignancies with negligible risk of metastasis or death such as adequately treated non-melanoma skin cancer or carcinoma in situ * AST or ALT greater than 3 times the upper limit of normal at screening * Serum creatinine greater than 2 times the upper limit of normal at screening * History of gastrointestinal surgery or gastrointestinal disease that may affect absorption of the study food, except simple appendectomy or hernia repair * Known hypersensitivity to the active ingredient or any component of the study food * Use of systemic antibiotics or bowel preparation agents within 2 weeks before screening * Intake of probiotics, prebiotics, or lactic acid bacteria or fermented milk products 4 or more times per week within 2 weeks before screening, excluding fermented foods included in a regular diet * Continuous use of protein supplements or muscle-related health functional foods within 1 month before screening * Use of medications that may affect muscle mass or muscle strength within 3 months before screening, including systemic corticosteroids (oral or injectable), testosterone, growth hormone preparations, selective androgen receptor modulators, and anti-obesity drugs * Severe alcohol use disorder according to DSM-5 diagnostic criteria * Continuous use of psychiatric medication for schizophrenia, bipolar disorder, or severe major depressive disorder, excluding intermittent medication for sleep disturbance * Participation in another clinical trial within 3 months before screening, or current participation in another clinical trial * Women who are pregnant, breastfeeding, or planning to become pregnant during the study period * Any other condition that, in the judgment of the principal investigator, may affect the safety of the participant or the integrity of the study results

Outcomes

Primary Outcomes

Change from baseline in peak torque per body weight of the quadriceps and hamstrings (average of left and right)